Cleared Traditional

JMS HALO APPLICATION TRAY (K864969) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K864969 · Jerome Medical · General & Plastic Surgery device
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Feb 1987
Decision
58d
Days
Class 1
Risk

K864969 is an FDA 510(k) clearance for the JMS HALO APPLICATION TRAY. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on February 18, 1987 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jerome Medical devices

Submission Details

510(k) Number K864969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 22, 1986
Decision Date February 18, 1987
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KDD Kit, Surgical Instrument, Disposable

Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K864969.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
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BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · Baxter Healthcare Corp · Jul 1991
EMERGENCY DEPARTMENT LACERATION KIT-
K802557 · Johnson & Johnson Professionals, Inc. · Nov 1980